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U.S. FDA Medical Device Reusable Vein Stripper Requirements


FDA Medical Device Definition: A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

Registrar Corp assists Reusable Vein Stripper companies with:

  • FDA Reusable Vein Stripper Establishment Registration
  • FDA Reusable Vein Stripper Listing
  • FDA Reusable Vein Stripper Label Requirements and Exceptions
  • FDA Reusable Vein Stripper Import Information
  • FDA Reusable Vein Stripper Detentions (Reusable Vein Stripper Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Reusable Vein Stripper Manufacturers (Reusable Vein Stripper Suppliers)
       - Reusable Vein Stripper Distributors
       - Reusable Vein Stripper Processors
       - Reusable Vein Stripper Repackers
       - Reusable Vein Stripper Relabelers
       - Reusable Vein Stripper Exporters
       - Reusable Vein Stripper Importers
For more information about Reusable Vein Stripper Medical Devices, simply click below:






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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